Healthcare Industry News:  Merit Medical Systems 

Devices FDA

 News Release - November 28, 2007

Merit Medical Announces 510(k) Notification for Two Additional Products

SOUTH JORDAN, Utah, Nov. 28, 2007 (Healthcare Sales & Marketing Network) -- Merit Medical Systems Inc. (NasdaqGS:MMSI ), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology and radiology procedures, announced today that it has received notification from the FDA of 510(k) clearance for the All Star(tm) hemostasis valve and the Prelude(tm) marker tip introducer sheath.

The All-Star(tm) hemostasis valve's patented design maintains a fluid-tight seal around interventional devices. It allows the user to one-handedly manipulate wires and catheters without completely opening the valve, thereby reducing patient blood loss.

The Prelude(tm) marker tip introducer sheath allows visualization of the sheath tip for precise placement during interventional and diagnostic procedures.

``These are high-margin products that we believe will enhance Merit's revenue growth and profitability in 2008,'' said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. ``Merit's R&D team continues to deliver new products at a record pace, validating the success of the restructuring plan we implemented a few years ago.''


Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology and radiology. Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 90 individuals. Merit employs approximately 1,520 people worldwide, with facilities in Salt Lake City and South Jordan, Utah; Angleton, Texas; Richmond, Virginia; Maastricht and Venlo, The Netherlands; and Galway, Ireland. For additional information, visit Merit's web site at

Statements contained in this release, which are not purely historical, are forward-looking statements within the meaning of the Private Securities Litigation Act of 1995 and are subject to risks and uncertainties such as those described in Merit's Annual Report on Form 10-K for the year ended December 31, 2006. Such risks and uncertainties include product recalls and product liability claims; infringement of Merit's technology or the assertion that Merit's technology infringes the rights of other parties; termination of relationship with suppliers, or failure of suppliers to perform; inability to successfully manage growth through acquisitions; delays in obtaining regulatory approvals, or the failure to maintain such approvals; concentration of Merit's revenues among a few products and procedures; development of new products and technology that could render Merit's products obsolete, market acceptance of new products, introduction of products in a timely fashion, price and product competition, availability of labor and materials, cost increases, and fluctuations in and obsolescence of inventory; volatility of the market price of Merit's common stock; foreign currency fluctuations; key personnel; work stoppage or transportation risks; modification or limitation of governmental or private insurance reimbursement, changes in health care markets related to health care reform initiatives; and other factors referred to in Merit's Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results may differ materially from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and Merit assumes no obligation to update or disclose revisions to those estimates.

Source: Merit Medical Systems

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